The Summer Camp Study: Feasibility of Outpatient Automated Blood Glucose Control With a Bi-Hormonal Bionic Endocrine Pancreas in a Pediatric Population at the Clara Barton Diabetes Camps
Bi-hormonal Bionic Pancreas
+ Usual Care
Maladies Auto-immunes+15
+ Diabète Mellitus
+ Maladies du système endocrinien
Étude thérapeutique
Résumé
Date de début de l'étude : 1 avril 2013
Date à laquelle le premier participant a commencé l'étude.The bionic pancreas will be compared to usual care in a crossover design in which each volunteer will serve as his or her own control. Each volunteer will be under closed-loop glucose control for five days and usual camp level of diabetes care for five days in random order with a one day washout period in between.
Protocole
Cette section fournit des détails sur le plan de l'étude, y compris la manière dont l'étude est conçue et ce qu'elle évalue.32 participants à inclure
Nombre total de participants que l'essai clinique vise à recruter.Traitement
Éligibilité
Les chercheurs recherchent des patients correspondant à une certaine description appelée critères d'éligibilité : état de santé général ou traitements antérieurs du patient.Tout sexe
Le sexe biologique des participants éligibles à s'inscrire.De 12 à 20 ans
Tranche d'âge des participants éligibles à participer.Volontaires sains non autorisés
Indique si les individus en bonne santé et ne présentant pas la condition étudiée peuvent participer.Conditions
Pathologie
Critères
Inclusion Criteria: Age 12-20 years with type 1 diabetes for at least one year. Diabetes managed using an insulin infusion pump and rapid- or very-rapid-acting insulins including insulin aspart (NovoLog), insulin lispro (Humalog), and insulin glulisine (Apidra) for at least three months prior to enrollment. Otherwise healthy (mild chronic disease such as asthma will be allowed if well controlled that do not require medications that result in exclusion). Exclusion Criteria: Unable to provide informed assent Unable to comply with study procedures. Current participation in another diabetes-related clinical trial other than one that is primarily observational in nature. Total daily dose (TDD) of insulin that is > 2 units/kg. Pregnancy (positive urine HCG), plan to become pregnant in the immediate future, or sexually active without use of contraception Hypoglycemia unawareness (self-reported or legal guardian report of consistent lack of hypoglycemia symptoms when BG is < 50 mg/dl) End stage renal disease on dialysis (hemodialysis or peritoneal dialysis). History of prolonged QT or arrhythmia History of congenital heart disease or current known cardiac disease Acute illness (other than non-vomiting viral illness) or exacerbation of chronic illness other than type 1 diabetes at the time of the study. Seizure disorder or history of hypoglycemic seizures or coma in the last five years Untreated or inadequately treated mental illness (indicators would include symptoms such as psychosis, hallucinations, mania, and any psychiatric hospitalization in the last year), or treatment with second generation anti-psychotic medications, which are known to affect glucose regulation. Electrically powered implants (e.g. cochlear implants, neurostimulators) that might be susceptible to radiofrequency interference. Use non-insulin, injectable (e.g. exenatide, pramlintide) or oral (e.g. thiazolidinediones, biguanides, sulfonylureas, meglitinides, dipeptidyl peptidase-4 inhibitors, acarbose)anti-diabetic medications. History of adverse reaction to glucagon (including allergy) besides nausea and vomiting. Unwilling or unable to completely avoid acetaminophen during the usual care and closed-loop BG control portions of the study. History of eating disorder such as anorexia, bulimia, "diabulemia" or omission of insulin to manipulate weight History of intentional, inappropriate administration of insulin leading to severe hypoglycemia requiring treatment Any factors that, in the opinion of the principal investigator, would interfere with the safe completion of the study procedures.
Plan de l'étude
Découvrez tous les traitements administrés dans cette étude, leur description détaillée et ce qu'ils impliquent.2 groupes d'intervention sont désignés dans cette étude
Cette étude ne comporte pas de groupe placebo.
Groupes de traitement
Groupe I
ExpérimentalGroupe II
Comparateur actifObjectifs de l'étude
Objectifs principaux
Objectifs secondaires
Centres d'étude
Ce sont les hôpitaux, cliniques ou centres de recherche où l'essai est conduit. Vous pouvez trouver le site le plus proche de vous ainsi que son statut.Cette étude comporte 1 site
Massachusetts General Hospital
Boston, United StatesOuvrir Massachusetts General Hospital dans Google Maps